HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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TORISEL®(temsirolimus)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
TORISEL® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
TORISEL is indicated for the treatment of advanced renal cell carcinoma.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Advanced Renal Cell Carcinoma
The recommended dose of TORISEL for advanced renal cell carcinoma is 25 mg administered as an...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
TORISEL (temsirolimus) is supplied as a kit consisting of the following:
TORISEL (temsirolimus) injection (25 mg/mL). The TORISEL vial contains temsirolimus at a concentration of 25 mg/mL....
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Contraindications
4 CONTRAINDICATIONS
TORISEL is contraindicated in patients with bilirubin >1.5×ULN [see Warnings and Precautions (5.2)].
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity/Infusion Reactions
Hypersensitivity/infusion reactions, including but not limited to flushing, chest pain, dyspnea,...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Agents Inducing CYP3A Metabolism
Co-administration of TORISEL with rifampin, a potent CYP3A4/5 inducer, had no significant effect on...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in...
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Overdosage
10 OVERDOSAGE
There is no specific treatment for TORISEL intravenous overdose. TORISEL has been administered to patients with cancer in phase 1 and 2 trials with repeated intravenous doses as high as 220 mg/m...
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Description
11 DESCRIPTION
Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent.
Temsirolimus is a white to off-white powder with a molecular formula of C56H87NO...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Temsirolimus is an inhibitor of mTOR (mammalian target of rapamycin). Temsirolimus binds to an intracellular protein...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with temsirolimus. However,...
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Clinical Studies
14 CLINICAL STUDIES
A phase 3, multi-center, three-arm, randomized, open-label study was conducted in previously untreated patients with advanced renal cell carcinoma (clear cell and non-clear cell histologies). The...
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References
15 REFERENCES
- OSHA Hazardous Drugs. OSHA. https://www.osha.gov/SLTC/hazardousdrugs/index.html.
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC 0008-1179-01 TORISEL (temsirolimus) injection, 25 mg/mL.
Each kit is supplied in a...
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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Allergic (Hypersensitivity/Infusion) Reactions
Patients should be informed of the possibility of serious...
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.